Welcome! ISO9001:2008 Information Session

Transcription

1 Welcome! Information Session Presented by Mickey Jawa - SatiStar

2 Outcomes Who is SatiStar? The ISO revision process Understand the revisions in What s next?

3 About SatiStar

4 Business Performance Improvement Consulting Toronto London Pittsburgh Brisbane Singapore

5 Our mission To experience the joy of helping our clients excel at what they do.

6 Our Expertise...

7 Some of our clients... Capulum Cable Technologies Ltd. Kuriyama Westburne Standard Products Kingston UNITED CONVEYOR CORPORATION

8 You can t beat the experience! Manufacturing Adhesives Mold Design & Mfg. Architecture Non-Manufacturing Maintenance Aerospace Nursery Equipment Contractors Marketing Agriculture Optical Customer Service Medical Appliance Paint Dental Outsourcing Automation Pharmaceuticals Distribution Publishing Automotive Photographic Duct Cleaning Repair & Overhaul Blood Products Plastics E-Commerce Retail Research & Develop. Brewing Point of Sale Systems Environment Recycling Chemicals Porcelain Finance Retail Computers Printing Government Safety Construction Pulp & Paper Health Sales Consumer Elect. Residential Homes Health Services Scheduling Defense Robotics Hospitality Security Electronics Rolled Goods Human Resources Shipping Flooring Satellite Information Systems Software Food & Ferment. Silkscreening Insurance Telecommunications Furniture Steel Laboratory Transportation Heavy Equipment Toner Cartridges Logistics University Industrial HVAC Tool & Die Maintenance Warehousing Label Manufacturing Vision Management Consulting Wholesale Machining Wire & Cable Metals Wood Products

9 We walk the talk... SatiStar is an registered organization

10 ISO9001 Revision Process

11 The ISO9000 Family of Standards (32) Requirements ISO9000:2005 Fundamentals and vocabulary ISO9004:2000 Guidelines for performance improvement ISO10005:2005 Guidelines for quality plans ISO10006:2003 Guidelines for project management ISO10007:2003 Guidelines for configuration management ISO10012:2003 Requirements for measurement systems ISO10013:2001 Guidelines for documentation ISO10014:2006 Guidelines for realizing financial & economic benefits ISO10015:1999 Guidelines for training ISO10017:2003 Guidance on statistical techniques for ISO9001 ISO10019:2005 Guidance on selecting QMS consultants and using their services ISO19011:2002 Guidelines for auditing... others, including many industry-specific guidelines for application

12 History CAN Z299 BS5750 ISO9000:87 ISO9000:94 ISO13485 ISO14000 ISO9001:00 TL9000 QS9000 AS9100 ISO18000 DIN TS16949:02 AS9100A/B ISO20000 ISO9001:08 TS16949:08 AS9100C

13 International Organization for Standardization Technical Committee - TC176 Quality Management & Quality Assurance Trevor Smith Kodak TC176 Chairperson David Zimmerman CSA TC176 Secretary Sub-Committee - SC2: Quality systems Manages revisions to ISO9001, etc. Dr. John Davies UK SC2 Chairperson Charles Corrie BSI SC2 Secretary Reviewers: 67 Participating countries 9 Observing countries North America: SCC, ANSI and DGN representatives

14 ISO Standard Approval Process Proposal Working Draft (WD) Committee Draft (CD) Draft International Standard (DIS) Final Draft International Standard (FDIS) Standard Published

15 ISO Standard Approval Process Proposal Working Draft (WD) Committee Draft (CD) Draft International Standard (DIS) Final Draft International Standard (FDIS) months Standard Published

16 Focus ISO9000:87 Documentation ISO9000:94 Prevention ISO9000:00 Processes ISO9000:08 PROCESSES!!!!

17 Process Approach Sales O/E Scheduling Purchasing Design & Development Manufacturing Warehousing Shipping Receiving Customer Satisfaction Management Review Internal Audit Corrective Action Preventive Action Continual Improvement IM&T NCR MRB Document Control Training Recruitment & Selection Performance Appraisal Business Planning Calibration Preventive Maintenance Typical processes in most companies

18 Process Approach Policy O & T NCR CI KPI CA & PA I & T Calibration Inputs Planning Process Outputs ID & Trace. Inf. & Work Env. Resources Interaction PM Competence Procedures & WI Other Processes Document Control

19

20 Overview of changed requirements Requirements Quality Mgt System Management Resource Realization Measurement, Analysis & Improvement 4.1 General Requirements 4.2 Documentation Requirements 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Quality Planning 5.5 Responsibility and Authority 5.6 Management Reviews 6.1 Resource Management 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment 7.1 Planning of Product Realization 7.2 Customer Related Processes 7.3 Design and Development 7.4 Purchasing 7.5 Production and Service Provision 7.6 Control of Monitoring & Measuring Devices 8.1 Measurement Analysis & Improvement 8.2 Monitoring and Measurement 8.3 Control Nonconforming Product 8.4 Analysis of Data 8.5 Improvement

21 Revision Summary Changes are mostly minor in nature Clause numbering maintained Clarification of wording Consolidation of sanctioned interpretations Improved alignment with ISO9004 & ISO14001 No intent to merge ISO9001 with other standards Intensified focus on process approach

22 Nature of Changes 83 changes 28 New requirements 30 Modified requirements 12 New notes 3 Revised notes 10 Deletions Analysis Red Big Change Blue Small Change

23 General Section Revisions New requirement Added the words its organizational environment, changes in that environment, and the risks associated with that environment; No impact for most organizations Introduction, 0.1 General The design and implementation of an organization s quality management system is influenced by: its organizational environment, changes in that environment, and the risks associated with that environment; its varying needs; its particular objectives; the products it provides; the processes it employs; its size and organizational structure. Additions are obvious things that all companies know

24 General Section Revisions New requirement Added the word statutory for clarity in Europe No impact for most organizations in NA to assess the organization s ability to meet customer, regulatory requirements applicable to the product, and the organization s own requirements. Introduction, 0.1 General to assess the organization s ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization s own requirements. Statutory = Legislative laws Regulatory = Lower authority laws

25 General Section Revisions New requirement Added the words to produce the desired outcome Process approach applies to all business processes that produce an outcome. Introduction, 0.2 Process Approach The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the process approach. Need to know what the desired outcome is. Major impact for most organizations Potential MAJOR impact You must use the Process Approach Inputs Planning Process Outputs

26 General Section Revisions Deleted requirement Modified requirement Introduction, 0.3 Relationship with ISO9004 Revised wording Similar meaning ISO9001 is related to ISO9004 No impact for most organizations The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement each other, but can also be used independently. Although the two International Standards have different scopes, they have similar structures in order to assist their application as a consistent pair. ISO9001 and ISO9004 are quality management system standards which have been designed to complement each other, but can also be used independently. Says that 9001 & 9004 are complementary in fewer words

27 General Section Revisions New requirement Added the word statutory for clarity in Europe No impact for most organizations in NA Introduction, 0.3 Relationship with ISO9004 It focuses on the effectiveness of the quality management system in meeting customer and applicable regulatory requirements. It focuses on the effectiveness of the quality management system in meeting customer and applicable statutory and regulatory requirements. Statutory = Legislative laws Regulatory = Lower authority laws

28 General Section Revisions 3 new requirements Introduction, 0.3 Relationship with ISO9004 Revised wording Similar meaning ISO9004 is intended for improvement of and guidance on ISO9001 systems No impact for most organizations ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organization's overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly in managing for the sustainable success of an organization. ISO 9004 is recommended as a guide for organizations whose top management wishes to extend the benefits of ISO 9001 in pursuit of systematic and continual improvement of the organization s overall performance. Says that 9004 provides guidance for 9001 (using slightly different wording)

29 General Section Revisions Modified requirement Introduction, 0.4 Compatibility with other management systems Revised wording Similar meaning Updated standard reference This International Standard has been aligned with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the user community. During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community. No impact for most organizations ISO14001 was revised in 2004

30 2 new requirements 1 Scope, 1.1 General Added the word statutory for clarity in Europe No impact for most organizations in NA a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. Statutory = Legislative laws Regulatory = Lower authority laws

31 Revised note Clarification of term product Added outputs of any realization process, including internal processes In this International Standard, the term product applies only to the product intended for, or required by, a customer. 1 Scope, 1.1 General - Note 1 In this International Standard, the term product only applies to the product intended for, or required by, a customer or the product realization processes. This applies to any intended output resulting from product realization processes. Major impact for most organizations Potential MAJOR impact Product includes the output of all processes. You must use the Process Approach

32 New note No impact for most organizations 1 Scope, 1.1 General - Note 2 Statutory and regulatory requirements can be expressed as legal requirements. Statutory / Regulatory = Legal requirements

33 New requirement 1 Scope, 1.2 Application Added the word statutory for clarity in Europe No impact for most organizations in NA Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements. Statutory = Legislative laws Regulatory = Lower authority laws

34 4 modified requirements 2 Normative reference Simplification Dated vs non-dated references No impact for most organizations Simplified way of saying that dated references must be used as cited, undated must be most current The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 9000:2000, Quality management systems Fundamentals and vocabulary. The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2005 Quality management systems Fundamentals and vocabulary.

35 Deleted requirement 3 Term and Definitions Revised wording Deleted references to 1994 version of the standard No impact for most organizations For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply. The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used: supplier organization customer The term organization replaces the term supplier used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term supplier now replaces the term subcontractor. For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply. Throughout the text of this International Standard, wherever the term product" occurs, it can also mean service. Deleted old terminology used on 1994 version

36 Modified requirement Modified Identify to Determine No impact for most organizations a) Identify the processes needed for the quality management system and their application throughout the organization (see 1.2) 4.1 General Requirements a) Determine the processes needed for the quality management system and their application throughout the organization (see 1.2) Changed identify to determine to avoid confusion about labeling processes

37 New requirement Added where applicable e) monitor, measure and analyse these processes, and 4.1 General Requirements e) monitor, measure where applicable, and analyse these processes, and Simplification. Don t have to measure all processes! No impact for most organizations Only need to monitor / measure where applicable

38 Revised Note Better aligned with standard s 8 th section 8.0 Measurement, analysis and improvement Removed should 4.1 General Requirements - Note 1 Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement. Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement. No impact for most organizations Aligns with Section 8 includes analysis & improvement

39 New note Clarification of outsourcing vs purchasing Potential impact for most organizations 4.1 General Requirements - Note 2 An outsourced process is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party. Outsourcing vs Purchasing How many processes do you outsource?

40 New note Must define all of your outsourced processes! Significant Impact on some organizations Will have a SIGNIFICANT impact for anyone who outsources: (training, PM, IA, mfg, design, testing, calibration, purchasing, transport, service, customer service, etc) 4.1 General Requirements - Note 3 New Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced processes can be influenced by factors such as: a) the potential impact of the outsourced process on the organization s capability to provide product that conforms to requirements; b) the extent to which the control for the process is shared; c) the capability of achieving the necessary control through the application of clause 7.4.

41 2 new requirements Deleted requirement Documentation Requirements General Revised wording for clarification No impact for most organizations d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and e) records required by this International Standard (see 4.2.4). c) Documented procedures and records required by this International Standard, and d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes. Clarification to ensure that records are kept

42 Revised note Greater flexibility in documentation Nice simplification opportunity No impact for most organizations Documentation Requirements Note 1 Where the term documented procedure appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. Where the term documented procedure appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document. Better definition of what a procedure can cover

43 New requirement Defines document of external origin better. Will require access to all relevant docs, incl. 9001:2008, 9000:2005, f) to ensure that documents of external origin are identified and their distribution controlled, and Control of documents f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and Minor impact for most organizations For most organizations this will be a simplification only need to control those that are needed for your QMS

44 2 modified requirements Control of records Revised wording for clarity No impact for most organizations Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records. Records shall remain legible, readily identifiable and retrievable. Revised wording for Control of Records

45 New requirement Management rep position cannot be outsourced! Management Representative: Top management shall appoint a member of management who, Top management shall appoint a member of the organization s management who, No impact for most organizations Management Rep must be an employee

46 Modified requirement Revised wording for clarity No impact for most organizations Human Resources - General Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience. Product quality = conformity to product requirements

47 New note Increases scope to all people performing any task in the QMS! Will have an impact on most organizations Human Resources - Note 1 Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system. Training / Job Description scope has increased

48 No change Competence, training and awareness The organization shall a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken, The organization shall a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken,

49 New requirement Infrastructure includes IS (verbal, paper, IT) c) supporting services (such as transport or communication). 6.3 Infrastructure c) supporting services (such as transport, communication or information systems). Some impact across the entire organization (process approach) Infrastructure includes IS

50 New note Better defines work environment Allows auditors to investigate EHS issues could be significant 6.4 Work Environment - Note 1 The term "work environment" relates to conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting, or weather). Defines work environment more completely.

51 2 new requirements 7.1 Planning of product realization Revised wording to include planning of measurement activities No impact for most organizations b) the need to establish processes, documents, and provide resources specific to the product; c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance; b) the need to establish processes and documents, and to provide resources specific to the product; c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance; Need to include measurement activities in the quality plans

52 2 modified requirements Determination of requirements related to the product Revised wording Clarification more specific (not just vaguely related... actually applies, and necessary) c) statutory and regulatory requirements related to the product, and d) any additional requirements determined by the organization. c) statutory and regulatory requirements applicable to the product, and d) any additional requirements considered necessary by the organization. No impact for most organizations Need to determine requirements that are both applicable and necessary (vs related, and anything you can think of)

53 New note Better defines post delivery activities Potentially significant impact on some organizations Customer Related Processes - Note 1 Post delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal. Scope includes post-delivery activities

54 New note Greater flexibility No impact for most organizations Design & Development - Note 1 Design and development review, verification and validation have distinct purposes. They may be conducted and recorded separately or in any combination as suitable for the product and the organization. Guidance on design stages

55 New note Guidance No impact for most organizations Design & Development - Note 1 Information for production and service provision may include details for the preservation of product. Design output must include preservation

56 New requirement Clarifies that release applies to the product Control of production and service provision f) the implementation of release, delivery and postdelivery activities. f) the implementation of product release, delivery and postdelivery activities. Some auditors may require evidence of this for all internal processes No impact for most organizations Clarifies that release applies to the product

57 New requirement Clarifies special process Easier because it only focuses on consequent deficiencies No impact for most organizations Validation of processes for production and service provision The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered. Better definition of special processes

58 2 new requirements Clarifies that identification applies throughout realization Clarifies that traceability records must be maintained May have an impact on some Identification and traceability The organization shall identify the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4). The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization. Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4). Identification & traceability requirements increased

59 2 modified requirements Clarified organization s responsibility No impact for most organizations If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4) Customer property If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer and maintain records (see 4.2.4). You are responsible for reporting issues with customer-owned property, and maintaining records

60 2 new requirements Clarification of application of preservation No impact for most organizations Preservation of product The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product. The organization shall preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product. Improved definition of preservation.

61 2 deleted requirements Modified requirement 7.6 Control of monitoring and measuring devices Deleted reference Revised wording for clarity Deleted note No impact for most organizations The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1). c) be identified to enable the calibration status to be determined; The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements c) have identification in order to determine its calibration status; NOTE See ISO and ISO for guidance. Deleted reference to for calibration

62 Modified requirement Clarifies conformity to requirements 8.1 Measurement, Analysis & Improvement - General a) to demonstrate conformity of the product, a) to demonstrate conformity to product requirements, No impact for most organizations Product quality = conformity to product requirements

63 New note Guidance May help some understand requirement better No impact for most organizations Monitoring & Measurement - Note 1 Monitoring customer perception may include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, dealer reports. Guidance on measuring customer satisfaction

64 New requirement Modified requirement Internal audit Wording made more clear Records unambiguously required No impact for most organizations depends on your audit records The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure. A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. Records of the audits and their results shall be maintained (see 4.2.4). Records of audits & audit results are required

65 New requirement Modified requirement Internal audit Revised wording to include corrections as well as corrective actions per ISO9000:2005 Revised note to reflect new standard No impact for most organizations The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. NOTE See ISO , ISO and ISO for guidance. The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. NOTE See ISO for guidance. Correction = fix Corrective action = RCA & fix root cause Do you have ISO19011?

66 Deleted requirement Removed to make application more general Process Conformity Potential significant impact for some organizations Monitoring and measurement of processes These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate. Removed emphasis on product conformity and replaced it with process conformity

67 New note Guidance Potential impact on some organizations Monitoring and measurement of processes -Note 1 When determining suitable methods, it is advisable that the organization consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system. Guidance on choosing which processes to measure

68 New requirement Modified requirement Monitoring and measurement of product Clarifies that intent is to protect the customer No impact for most organizations Records shall indicate the person(s) authorizing release of product (see 4.2.4). Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. Records shall indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4). The release of product and delivery of service to the customer shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. Monitor & measure product in order to protect the customer

69 New requirement 2 modified requirements 8.3 Control of nonconforming product Revised wording for clarity No impact for most organizations Simplified control of non-conforming product The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. The organization shall deal with nonconforming product by one or more of the following ways: When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity. A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product. Where applicable, the organization shall deal with nonconforming product by one or more of the following ways: d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.

70 Modified requirement Corrective action Causes Will impact most organizations The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. f) Reviewing the effectiveness of the corrective action taken Will affect everybody Improve your root causes analysis!

71 Modified requirement Preventive action Causes Will impact most organizations The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. f) Reviewing the effectiveness of the preventive action taken Will affect everybody Improve your root causes analysis!

72 Summary of Significant Changes Must use process approach to all processes Expanded scope of outsourced processes (training, mtce, IA, mfg, design, testing, calib, purch, transport, service, customer service, etc) Root Cause Analysis (Corrective Action & Preventive Action) Don t have to measure all processes Expanded definition of Work Environment Identify status throughout the entire realization process Post-delivery activities expanded to include non-contractual activities

73 What s Next? - Nov, 2008 New applications for registration No new registrations in 1 year Grace period for upgrades certificates obsolete in 2 years Modifying policy manual is easy Implementing process modifications relatively easy Deploying process approach might be complex

74 Training Session Feb Topics: Process mapping and analysis Process auditing Where: Mississauga When: Feb (3 days) Cost: $949 + GST

75 Need Help? 1. Log in Join 2. About us White Papers Information Session - Revision Presentation

76